Pressure Rise Time Modulation During Volume-Guaranteed Neonatal Ventilation

March 8, 2026 updated by: Ferid Aliyev, Hacettepe University

Short-term Physiological Effects of Pressure Rise Time Modulation During Volume-Guaranteed Neonatal Ventilation

This study investigates the short-term physiological effects of pressure rise time modulation during volume-guaranteed ventilation in neonates. Pressure rise time is an adjustable parameter that influences how quickly inspiratory pressure reaches the target level during mechanical ventilation.

In this study, different pressure rise time settings will be applied during volume-guaranteed ventilation, and their effects on respiratory parameters, gas exchange, and patient-ventilator interaction will be evaluated. The aim is to determine whether modulation of pressure rise time has measurable short-term physiological effects in ventilated neonates and to identify optimal ventilator settings that may improve respiratory support.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mechanical ventilation is frequently required in neonatal intensive care units, particularly for preterm infants with respiratory distress. Volume-guaranteed ventilation is commonly used because it helps maintain stable tidal volumes while minimizing ventilator-induced lung injury.

Pressure rise time is a ventilator parameter that determines how quickly inspiratory pressure reaches the target level at the beginning of each breath. Alterations in pressure rise time may influence inspiratory flow characteristics, patient-ventilator synchrony, and overall respiratory mechanics. However, limited data are available regarding the short-term physiological effects of pressure rise time modulation during volume-guaranteed ventilation in neonates.

The objective of this study is to evaluate the short-term physiological responses to different pressure rise time settings during volume-guaranteed ventilation in neonates receiving respiratory support in the neonatal intensive care unit. Respiratory parameters, ventilator measurements, and gas exchange indicators will be monitored while sequentially applying different pressure rise time settings.

The findings of this study may contribute to a better understanding of ventilator parameter optimization in neonatal respiratory care and may help guide clinicians in selecting ventilator settings that improve patient-ventilator interaction and respiratory stability.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inclusion Criteria:
  • Neonates receiving volume-guaranteed mechanical ventilation
  • Patients monitored in the neonatal intensive care unit
  • Clinically stable neonates undergoing ventilator setting adjustments

Exclusion Criteria:

  • Major congenital anomalies affecting respiratory function
  • Hemodynamic instability
  • Patients requiring immediate ventilator mode changes or emergency interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pressure Rise Time Modulation
Neonates receiving volume-guaranteed ventilation in whom different pressure rise time settings are sequentially applied to evaluate short-term physiological effects.
Device: Pressure Rise Time Adjustment
Adjustment of pressure rise time settings during volume-guaranteed neonatal ventilation to evaluate short-term physiological responses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peak inspiratory pressure
Time Frame: Immediately after pressure rise time adjustment during the study procedure
Assessment of changes in peak inspiratory pressure following different pressure rise time settings.
Immediately after pressure rise time adjustment during the study procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean airway pressure
Time Frame: Immediately after ventilator adjustment
Evaluation of changes in mean airway pressure associated with different pressure rise time settings during volume-guaranteed ventilation.
Immediately after ventilator adjustment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Ferid Aliyev, MD, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Aliyev F. Pressure rise time modulation during neonatal ventilation: study protocol. Hacettepe University Faculty of Medicine. 2026.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2023

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KA-21062 (Other Identifier: Hacettepe University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional data protection policies and patient confidentiality considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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